Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HZH · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842924 | ORANGE G, 1% | E K Ind., Inc. | 1984-09-07 | 44 | 0 |
| K822038 | VOLU-SOL ORANGE G-6(GILLS-MOD | Volu Sol Medical Industries | 1982-08-03 | 22 | 0 |
| K811825 | ORANGE G-6 | Surgipath | 1981-07-10 | 11 | 0 |
| K800323 | VOLU-SOL ORANGE G-6 STAIN | Volu Sol Medical Industries | 1980-02-22 | 10 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda